Establishment of Molecular Classification Models for Early Diagnosis of Digestive System Cancers
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ClinicalTrials.gov Identifier: NCT05431621 |
Recruitment Status :
Completed
First Posted : June 24, 2022
Last Update Posted : April 17, 2024
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Condition or disease |
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Esophageal Cancer Gastric (Stomach) Cancer Colorectal Cancer Hepatocellular Carcinoma |
Study Type : | Observational |
Actual Enrollment : | 2430 participants |
Observational Model: | Case-Control |
Time Perspective: | Cross-Sectional |
Official Title: | Establishment of Molecular Classification Models for Early Diagnosis of Digestive System Cancers |
Actual Study Start Date : | November 15, 2020 |
Actual Primary Completion Date : | June 30, 2023 |
Actual Study Completion Date : | July 31, 2023 |
Group/Cohort |
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Digestive system cancer group
A total of about 1035 cases are expected to be enrolled, including 432 cases in stage I and 603 cases in II-IV.
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Negative group
985 healthy individuals.
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High risk group
410 cases with precancerous diseases.
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- Establish ctDNA-targeted sequencing models for early detection of esophageal, gastric, colorectal and hepatocellular cancer, and evaluate the diagnosis value [ Time Frame: assessed up to 1 year ]To discover the characteristic targets of ctDNA methylation, fragment, and mutation in esophageal, gastric, colorectal cancers, and hepatocellular carcinoma, and establish the early detection panel. Then, evaluate the sensitivity and specificity of multi-cancer early detection models.
- Establish and evaluate the non-invasive early detection model for hepatocellular carcinoma [ Time Frame: assessed up to 1 year ]To establish and evaluate the early detection model for hepatocellular carcinoma based on ctDNA methylation detection, ctDNA low-pass WGS, miRNA7™ and CTC detection.
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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Colorectal cancer, Esophageal cancer and Gastric (stomach) cancer Group
Inclusion Criteria:
- Aged 18 to 80, no gender limitation, no pregnant or breastfeeding for women;
- Those who can accept gastroscopy and/or total colonoscopy;
- Newly-diagnosed patients who had not received surgery, radiotherapy, chemotherapy, targeted therapy or other anti-tumor intervention;
- Stop anticoagulant drugs such as warfarin, aspirin, and bolivir for 1 week, and stop low molecular weight heparin that day;
- No previous history of other tumor diseases, and no abnormalities in the liver and kidney;
- No major trauma requiring blood transfusion treatment within one week.
Exclusion Criteria:
- Previous esophageal cancer, stomach cancer, bowel cancer and gastrointestinal adenoma;
- Have a history of other cancers;
- Systemic inflammatory response syndrome;
- Previously experienced esophageal, gastric or colorectal adenoma removal or tumor resection;
- Patients with Lynch syndrome in the family;
- A history of severe cardiovascular disease (e.g., previous myocardial infarction, coronary artery bypass grafting, coronary stenting, congestive heart failure, myocardial infarction within 6 months, or uncontrolled severe hypertension, etc.) who were deemed unsuitable for inclusion by the investigator;
- Have participated in an "interventional" clinical trial within the past 30 days and have taken the experimental drug;
- Unsuitable for this trial determined by the researchers;
- Failure to collect blood on time according to plan;
- The blood sample does not meet the requirements.
Hepatocellular Carcinoma Group
Inclusion Criteria:
- Applicable to all enrolled volunteers (1) Aged 18 to 80, no gender limitation, no pregnant or breastfeeding for women; (2) No previous history of malignancy in other sites; (3) To avoid the risk of bleeding caused by taking anticoagulants during sampling, the following provisions shall be made according to different types of samples: stop anticoagulant drugs such as warfarin, aspirin, and bolivir for 1 week, and stop low molecular weight heparin that day; the doctor in charge decides whether to stop anticoagulant drugs before blood draw, according to the specific situation of the volunteers, ; (4) No major trauma requiring blood transfusion treatment within one week;
- Only for patients with hepatocellular carcinoma (HCC). (1) Diagnosed with stage I-IV hepatocellular carcinoma; (2) Newly-diagnosed patients with liver cancer, who had not received surgery, radiotherapy, chemotherapy, targeted therapy or other anti-tumor intervention;
- Only for high-risk groups (1) Diagnosis of child-Pugh grade A or B, chronic hepatitis B or cirrhosis; (2) No history of liver cancer or malignancy in other sites;
- For healthy people only (1) Normal liver function test results on the day of blood collection; (2) No history of hepatitis B, hepatitis C and cirrhosis; (3) No history of liver cancer or malignancy in other sites.
Exclusion Criteria:
- Patients with liver cancer who have received surgery, radiotherapy, chemotherapy, targeted therapy;
- Cancer patients except HCC, or patients with liver metastasis;
- Systemic inflammatory response syndrome;
- A history of severe cardiovascular disease (e.g., previous myocardial infarction, coronary artery bypass grafting, coronary stenting, congestive heart failure, myocardial infarction within 6 months, or uncontrolled severe hypertension, etc.) who were deemed unsuitable for inclusion by the investigator;
- Have participated in an "interventional" clinical trial within the past 30 days and have taken the experimental drug;
- Unsuitable for this trial determined by the researchers;
- Failure to collect blood on time according to plan;
- The blood sample does not meet the requirements.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05431621
China, Shanghai | |
Xuhui Central Hospital, Shanghai | |
Shanghai, Shanghai, China, 200030 | |
Zhongshan Hospital of Fudan University | |
Shanghai, Shanghai, China, 200030 | |
Shanghai Public Health Clinical Center | |
Shanghai, Shanghai, China, 201500 | |
Qingpu Branch of Zhongshan Hospital Affiliated to Fudan University | |
Shanghai, Shanghai, China, 201700 |
Study Director: | Jian Zhou, Doctor | Fudan University | |
Study Director: | Yunshi Zhong, Doctor | Fudan University | |
Principal Investigator: | Rui Liu, Doctor | Singlera Genomics Inc. | |
Study Director: | Bin Yan, Doctor | Shanghai Zhongshan Hospital | |
Study Director: | Dongli He, Master | Xuhui Central Hospital, Shanghai |
Responsible Party: | Singlera Genomics Inc. |
ClinicalTrials.gov Identifier: | NCT05431621 |
Other Study ID Numbers: |
2019YFC1315802-01 |
First Posted: | June 24, 2022 Key Record Dates |
Last Update Posted: | April 17, 2024 |
Last Verified: | January 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
ctDNA markers DNA methylation DNA fragment feature |
miRNA CTC Cancer early detection |
Digestive System Neoplasms Stomach Neoplasms Gastrointestinal Neoplasms Neoplasms by Site |
Neoplasms Digestive System Diseases Gastrointestinal Diseases Stomach Diseases |